Federal Public Policy Briefings
Recorded
Navigating a Shifting Landscape: OMB's Uniform Guidance, Common Rule, Clinical Trial Remuneration, and Genomic Data Sharing
This Federal Policy Briefing addresses a range of major federal policy developments affecting the research community, including: PRIM&R's recently submitted joint public comment with AAHRPP and NACHRP on the OMB's proposed rule, "Regulation for Federal Financial Assistance" (known as Uniform Guidance); a discussion on possible revisions to the Common Rule and their implications; consideration of the pending RFI regarding safe harbor regulations under the federal anti-kickback statute for remuneration provided to individuals in connection with their participation in clinical trials; the briefing also includes discussion on the NIH's proposed revisions to its Genomic Data Sharing Policy and Controlled-Access Data Policy.
Guests:Nichelle Cobb, PhD, CIP, Senior Advisor for Strategic Initiatives, AAHRPP
Julie Kaneshiro, MA, NACHRP
Benjamin Silverman, MD, NACHRP
Ivy R. Tillman, EdD, CIP, Executive Director, PRIM&R
Understanding 21 CFR 50.54: When FDA-Regulated Pediatric Research Requires Federal Review
Research involving children that poses more than minor increase over minimal risk without direct benefit requires federal review under 21 CFR 50.54/46.407, yet sponsors, investigators, and IRBs frequently hesitate to pursue this pathway. This briefing examines why that hesitancy persists, the regulatory challenges it creates, and how stakeholders can better navigate federal referral to advance pediatric research while maintaining participant protections.
Guests:Luke Gelinas, PhD, Senior IRB Chair Director, AdvarraMelanie E. Bhatnagar, MD, serves as the Associate Director for Pediatric Education & Outreach and Acting Team Leader of Pediatric Ethics Program at the FDA
Artificial Intelligence (AI) and the Research Landscape
The persistent rise of artificial intelligence (AI) has significant impacts on the research enterprise. This policy briefing examines the state of artificial intelligence in the U.S., highlighting the current landscape, potential guardrails, and the implications of AI deployment for the research enterprise.
Guests: Tamiko Eto, MA CIPFounder & Owner of TechInHSR
Josh Fessel, MD, PhD, ATSFIndependent/Former NIH Rachele Hendricks-Sturrup, DHSc, MSc, MAResearch Director, Duke-Margolis Institute for Health Policy
Josh Fessel, MD, PhD, ATSFIndependent/Former NIH Rachele Hendricks-Sturrup, DHSc, MSc, MAResearch Director, Duke-Margolis Institute for Health Policy
New Approach Methodologies (NAMs)
This briefing is on the current state of New Approach Methodologies (NAMs) and recent federal policy developments that are reshaping the research landscape. Dr. Nicole C. Kleinstreuer, National Institutes of Health (NIH) Deputy Director for Program Coordination, Planning, and Strategic Initiatives, will share insights on NAM initiatives at the federal level and discuss key considerations for navigating this evolving landscape across the research enterprise.
Guest: Nicole C. Kleinstreuer, PhDNIH Deputy Director for Program Coordination, Planning, and Strategic Initiatives.
US National Primate Research Centers
This briefing discusses the US National Primate Research Centers (NPRC) and recent federal activities aimed at transitioning Oregon's NPRC.
Guest:Naomi Charalambakis, PhDDirector of Communications & Science PolicyAmericans for Medical Progress (AMP)
Guest:Naomi Charalambakis, PhDDirector of Communications & Science PolicyAmericans for Medical Progress (AMP)
Financial Accountability in Research Model for Federal Research Funding
This briefing explores the current federal research funding landscape, including new funding policies and mechanisms from the National Institutes of Health, the status of terminated NIH grants, and the future of indirect cost rates and Financial Accountability in Research Model for Federal Research Funding, known as FAIR.
Guest:
Heather H. Pierce JD, MPHSenior Director for Science Policy, Regulatory Counsel, Association of American Medical Colleges
Science and Regulatory Affairs at the Biotechnology Innovation Organization
This briefing featured Derek T. Scholes, PhD, vice president of Science and Regulatory Affairs at the Biotechnology Innovation Organization (BIO). This session offers a unique opportunity to hear directly from industry leadership on how evolving federal policies are shaping the future of research oversight and compliance.
Guest:Derek T. Scholes, PhDVice President of Science and Regulatory AffairsBiotechnology Innovation Organization (BIO)
Guest:Derek T. Scholes, PhDVice President of Science and Regulatory AffairsBiotechnology Innovation Organization (BIO)
Strengthening Research Ethics Across the U.S. and Canada
This briefing discussed, “Strengthening Research Ethics Across the U.S. and Canada.” Guest speakers from the Canadian Association of Research Ethics Boards (CAREB) will lead a cross-border conversation on strengthening research ethics and oversight in the United States and Canada.
Panelists:Delilah Ofosu-Barko, member of CAREB Board of DirectorsPast President, Canadian Association of Research Ethics Boards (CAREB)Director, Research OperationsTrillium Health Partners
Dean A. Tripp, PhD, member of CAREB Board of DirectorsProfessor in the Departments of Psychology, Anesthesiology, and UrologyChair of Queen’s University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board (HSREB)Queen's University, Kingston, Ontario, Canada
Panelists:Delilah Ofosu-Barko, member of CAREB Board of DirectorsPast President, Canadian Association of Research Ethics Boards (CAREB)Director, Research OperationsTrillium Health Partners
Dean A. Tripp, PhD, member of CAREB Board of DirectorsProfessor in the Departments of Psychology, Anesthesiology, and UrologyChair of Queen’s University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board (HSREB)Queen's University, Kingston, Ontario, Canada
New Approach Methodologies (NAMs)
This briefing examined new approach methodologies (NAMs) and the National Institutes of Health’s initiative to prioritize human-based research, including recent NIH funding announcements that align with this priority. (NIH Funding Announcements to Align with NIH Initiative to Prioritize Human-based Research | Grants & Funding).
Panelist:
Naomi Charalambakis, PhD
Director of Communications & Science Policy
Americans for Medical Progress
A supplemental document outlining key takeaways from the discussion is available at no cost to PRIM&R members or included with the purchase of this recording.
Where We’ve Been and Where We’re Going
This session provided an opportunity to reflect on PRIM&R’s 2025 advocacy efforts to advance ethical research oversight at the federal level and to support our community in navigating rapid policy changes.
Panelist:
Ivy R. Tillman, EdD, CIP
A supplemental document outlining key takeaways from the discussion is available at no cost to PRIM&R members or included with the purchase of this recording.
Federal Policy Developments
This briefing provided updates about federal policy developments and their implications for research oversight.
Panelists:
Molly Klote, MD,
Julie Kaneshiro, MA
A supplemental document outlining key takeaways from the discussion is available at no cost to PRIM&R members or included with the purchase of this recording.
Federal Public Policy Implications for Research Oversight
This briefing provided updates on federal policy developments and their implications for research oversight.
Panelists:
Jaime Hernandez JD, MBE, Practical Ethics-Research Solutions
Matthew Bailey, National Association for Biomedical Research
A supplemental document outlining key takeaways from the discussion is available at no cost to PRIM&R members or included with the purchase of this recording.